Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histological confirmation of gastric adenocarcinoma

• Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)

• For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)

• 18-75 years old

• No incurable factors such as cancer cell metastasis in other organs

• Written informed consent signed voluntarily

Locations
Other Locations
China
Xijing Hospital of Digestive Disease
RECRUITING
Xi'an
Contact Information
Primary
xiaohua Li, MD,PH.D
xjyylixiaohua@163.com
+8613474299901
Backup
zhenchang Mo
mzc131208@126.com
+8618229712293
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 154
Treatments
Experimental: The experimental group
Radical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface
Other: The control group
Radical gastrectomy +D2 lymphadenectomy
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov

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